Controlant

Saga’s GxP-validated data logger meets FDA 21 CFR Part 11 requirements for electronic records in pharmaceutical cold chain, generating compliant audit trails for each shipment batch. Real-time cellular transmission enables proactive intervention — a logistics provider can redirect a temperature-excursion shipment to the nearest qualified depot before product loss occurs. Integration with Controlant’s eDelivery Receipt system automates good-receipt temperature report generation in SAP and Oracle, eliminating manual data entry at receiving docks. Multi-language 21 CFR Part 11 electronic signature workflow manages deviation approvals and corrective action documentation. Battery management system monitors state-of-health and predicts end-of-life to prevent in-transit data logging gaps from depleted cells.